Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

NCT01241903 | Completed Phase 1 Results DMC

• 1 other identifier: 10-208-F1V
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.

Conditions

Acute Coronary Syndrome; Angioplasty, Transluminal, Percutaneous Coronary; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Blood Platelets

Keywords

Platelet activation; platelet leukocyte aggregates

Outcome Measures

Primary Outcomes (1)

• Platelet - Leukocyte Aggregates

  measured by flow cytometry

  within first 24 hours

Secondary Outcomes (1)

• Biomarkers of Platelet Function and Myocardial Necrosis

  up to 30 days

Study Arms (2)

Crestor

EXPERIMENTAL

Drug: rosuvastatin

sugar pill

PLACEBO COMPARATOR

Drug: placebo

Interventions

rosuvastatin DRUG

Patients (n = 54) presenting acute coronary syndrome/non-ST elevation myocardial infarction who present within 8 hours of symptom-onset will be randomized to two groups to receive rosuvastatin (40 mg oral dose) or placebo at the time of presentation, in addition to standard of care (aspirin, clopidogrel, low molecular weight heparin). Blood will be collected at baseline (time of enrollment, immediately prior to drug or placebo), at 6 - 8 hours, at 18 - 24 hours, and at 30 days for analysis of platelet - leukocyte co-aggregate formation, biomarkers of platelet - leukocyte interactions, and biomarkers of myocardial necrosis. Additional samples may be collected just after revascularization, in patients undergoing PCI. The group of patients treated with rosuvastatin will be maintained on rosuvastatin 20 mg daily and the group randomized to placebo will be given rosuvastatin (20 mg oral once daily) within 48 hoursof enrollment and after planned PCI, but before hospital discharge.

Also known as: crestor

Crestor

placebo DRUG

frequency and duration

sugar pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be between 18 and 80 years old.
• Subjects must be willing and able to give informed consent
• A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
• Subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin I or T greater that upper limit of normal (ULN) or creatine kinase-myocardial band (CK-MB) greater than ULN. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new ST-segment depression (≥1 mm) or transient (\<30 min) ST-segment elevation (≥ 1mm) in at least two contiguous leads.
• Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

You may not qualify if:

• Age \<18 years
• Age \> 80 years
• Use of Crestor in the past 30 days
• GFR (estimated) \<30 ml/min
• Hemodialysis
• History of liver failure
• Unexplained liver function abnormalities
• Current or planned use of cyclosporine or gemfibrozil
• Sepsis
• Hypotension
• Dehydration
• Trauma
• Severe metabolic, endocrine or electrolyte abnormality
• Recent (within the last 2 weeks) or planned (in the next month) major surgery
• HIV/AIDS with current of planned use of HIV protease inhibitors

Sponsors & Collaborators

• Susan Smyth: lead

Study Sites (1)

University of Kentucky Dept of Cardiology

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Susan S. Smyth
• Organization: University of Kentucky

ssmyt2@uky.edu

(859) 323-2274

Study Officials

• Susan S Smyth, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 28, 2017
• Results First Posted: June 24, 2014

Record last verified: 2017-02

Locations

US (1)